A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine

January 9, 2017 updated by: GlaxoSmithKline

A Randomized, Controlled, Phase II Study to Evaluate the Safety and Immunogenicity of Different Formulations of GlaxoSmithKline Biologicals' 11-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly as a 3-dose Primary Immunization (2-3-4 Month Schedule) Before 6 Months of Age

Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa

Study Type

Interventional

Enrollment (Actual)

689

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10315
        • GSK Investigational Site
      • Berlin, Germany, 12627
        • GSK Investigational Site
      • Berlin, Germany, 13355
        • GSK Investigational Site
      • Hamburg, Germany, 22307
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
        • GSK Investigational Site
      • Bretten, Baden-Wuerttemberg, Germany, 75015
        • GSK Investigational Site
      • Eppelheim, Baden-Wuerttemberg, Germany, 69214
        • GSK Investigational Site
      • Ettenheim, Baden-Wuerttemberg, Germany, 77955
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Germany, 77694
        • GSK Investigational Site
      • Oberkirch, Baden-Wuerttemberg, Germany, 77704
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, Germany, 77654
        • GSK Investigational Site
      • Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germany, 70469
        • GSK Investigational Site
      • Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
        • GSK Investigational Site
    • Bayern
      • Cham, Bayern, Germany, 93413
        • GSK Investigational Site
      • Herzogenaurach, Bayern, Germany, 91074
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81675
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80939
        • GSK Investigational Site
      • Noerdlingen, Bayern, Germany, 86720
        • GSK Investigational Site
      • Olching, Bayern, Germany, 82140
        • GSK Investigational Site
      • Weilheim, Bayern, Germany, 82362
        • GSK Investigational Site
      • Zwiesel, Bayern, Germany, 94227
        • GSK Investigational Site
    • Hessen
      • Koenigstein, Hessen, Germany, 61462
        • GSK Investigational Site
      • Marburg/Lahn, Hessen, Germany, 35039
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germany, 65205
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • GSK Investigational Site
      • Waren, Mecklenburg-Vorpommern, Germany, 17192
        • GSK Investigational Site
    • Niedersachsen
      • Salzgitter, Niedersachsen, Germany, 38226
        • GSK Investigational Site
      • Wolfenbuettel, Niedersachsen, Germany, 38302
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • GSK Investigational Site
      • Detmold, Nordrhein-Westfalen, Germany, 32756
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Germany, 44329
        • GSK Investigational Site
      • Erkrath, Nordrhein-Westfalen, Germany, 40699
        • GSK Investigational Site
      • Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Germany, 47798
        • GSK Investigational Site
      • Loehne, Nordrhein-Westfalen, Germany, 32584
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48159
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Bodenheim, Rheinland-Pfalz, Germany, 55294
        • GSK Investigational Site
      • Frankenthal, Rheinland-Pfalz, Germany, 67227
        • GSK Investigational Site
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67059
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
      • Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54290
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54294
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, Germany, 67547
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bredstedt, Schleswig-Holstein, Germany, 25821
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24937
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24939
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24943
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24944
        • GSK Investigational Site
      • Husum, Schleswig-Holstein, Germany, 25813
        • GSK Investigational Site
      • Neumuenster, Schleswig-Holstein, Germany, 24534
        • GSK Investigational Site
    • Thueringen
      • Lobenstein, Thueringen, Germany, 07356
        • GSK Investigational Site
      • Weimar, Thueringen, Germany, 99425
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.

Exclusion criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period.
  • Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination
Time Frame: 1 Month after dose 3
1 Month after dose 3

Secondary Outcome Measures

Outcome Measure
Time Frame
1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa.
Time Frame: 1 Month after dose 3
1 Month after dose 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: 103488
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: 103488
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: 103488
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 103488
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 103488
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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